Belite Bio, Inc(NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that it has entered into a subscription agreement with its wholly owned subsidiary, Belite Bio (HK) Limited ("Belite HK"), for assignment of Belite Bio's rights, title, interests and obligations under the exclusive license agreement with Trustees of Columbia University in the City of New York ("Columbia University"), in consideration for subscription of Belite HK's ordinary shares.
The foregoing assignment to Belite HK, Belite Bio's wholly owned subsidiary, was aimed to optimize the tax structure of the Company and, in the event that the Company enters into any sub-licensing or collaboration in the future, to fulfill the economic substance requirements under the Cayman Islands law. This assignment will not affect Belite Bio's business and operations.
A Russian air strike that hit a major thermal power station in the city of Burshtyn in western Ukraine on Wednesday has caused "quite serious" damage, the region's governor said on Thursday.
"Unfortunately there is destruction, and it is quite serious," Svitlana Onyshchuk, Ivano-Frankivsk's governor, said on Ukrainian television.
Gilead Sciences has new data showing COVID drug Veklury maintained efficacy despite changes in a coronavirus structure it targets, just as the company explores expedited ways to launch a pivotal trial for an investigational oral antiviral.
Compared with the original SARS-CoV-2 virus, Veklury (remdesivir) showed no major shifts in its ability to tackle coronaviruses with substitutions in the RNA-dependent RNA polymerase (RdRp), according to data presented at IDWeek 2022. Also known as nsp12, RdRp is a protein key in the replication of RNA viruses like SARS-CoV-2.
Coronaviruses with RdRp mutations isolated from patients in the phase 3 ACTT-1 trial—which got Veklury its FDA approval—showed up to about a 3.4-fold decrease in their susceptibility to Veklury compared with the original virus, the data showed. The fold change was measured by increases in half-maximal effective concentration of the drug, or EC50, and investigators called the difference “low.” ACTT-1 was conducted in 2020, before the delta and omicron variants were identified.
What’s more, the RdRp substitutions didn’t seem to affect clinical outcomes. Among Veklury takers who were eligible for this analysis, 67% of patients with the mutations recovered from COVID, compared with 58% of those without the mutations.
Because Veklury targets RdRp, theoretically the drug might not work as well if the protein underwent major structural changes, Anu Osinusi, Gilead’s vice president of clinical research for hepatitis, respiratory and emerging viruses, explained in an interview with Fierce Pharma.
The new data were consistent with other analyses Gilead has done, Osinusi said, and they continue to “bolster the story that there is a high barrier to resistance developing against remdesivir in patients.”
The results were better than findings from a recent Science Translational Medicine study. In that study, in which several Gilead scientists participated, researchers reported multiple pathways, including combinations of RdRp substitutions, that could give the coronavirus varying degrees of resistance to Veklury.
Introducing one specific combo of substitutions resulted in 38-fold Veklury resistance but also a viral replication defect, the study found. However, as the researchers noted, the substitutions selected from lab dishes merely described possible pathways to Veklury-resistant mutations, and that they were either rare or simply not detected in the more than 6 million publicly available RdRp sequences with or without Veklury treatment.
Anu Osinusi (Gilead Sciences)
Watching for mutants has become a main theme in the fight against COVID. Antibody drugs like Regeneron’s REGEN-COV have lost their emergency use authorizations because of reduced activity against omicron. Most SARS-CoV-2 variants identified show mutations on the spike protein on the surface of the virus, making neutralizing antibody therapies that target the protein ineffective.
“To date, we haven’t really seen any major genetic changes in any of the variants of concern, or even variants of interest, that have emerged that would significantly alter that viral RNA polymerase that is targeted by Veklury,” Osinusi said.\
Still, as COVID cases drop, Veklury sales declined 46% year-over-year in the second quarter to $445 million despite an expanded FDA approval for non-hospitalized patients in January. Veklury’s recent decrease also has Pfizer’s more convenient oral antiviral Paxlovid to thank. But the Pfizer therapy has its own problem, including potentially dangerous drug-drug interactions and reported fast COVID rebound. That’s why Gilead is working on its own oral COVID drug.
Gilead is moving a remdesivir prodrug coded GS-5245 “with full speed” potentially across the disease spectrum, Osinusi said. As the COVID treatment landscape is changing, the company is collaborating with global health authorities to launch a phase 3 global clinical trial that will “prioritize sites that can move quickly with clinical trial enrollment,” a Gilead spokesperson told Fierce Pharma. The California drugmaker previously disclosed a phase 1 trial for GS-5245 in January.
The proposed phase 3 trial will be randomized and double-blinded, pitting GS-5245 against placebo in non-hospitalized COVID patients who are at high risk of progression to hospitalization. Investigators will measure the rate of COVID-related hospitalization and all-cause death by day 29 as the trial’s primary endpoint, according to Gilead. The trial hasn’t started enrolling, pending endorsement from regulatory authorities, the spokesperson said.
Veklury remains a standard of care for COVID, “but we also recognize the limitations of it being an intravenous agent,” Osinusi said. “There is a need for having additional oral antiviral agents because that’s really when you’re going to be able to meet the needs of the broader population.”
As GSK looks to cement its vaccine dynasty over the coming years, the company continues to polish its “crown jewel” Shingrix. Now, a fresh batch of long-term data suggests the shot’s protective luster lasts at least a decade.
Overall, vaccination with Shingrix conferred “at least” 10 years of protection against shingles in adults ages 50 and older, GSK said Wednesday, citing interim results from the vaccine’s late-stage extension study Zoster-049.
More specifically, Shingrix’s overall efficacy landed above 80% during a follow-up period of roughly six to 10 years post-immunization, the British drugmaker said.
The provisional win bodes well for GSK’s plan to grow Shingrix sales to £4 billion by 2026. To get there, the company has said it will intensify Shingrix efforts in the U.S. and launch the shot in around 35 countries worldwide in the coming years.
Last summer, commercial chief Luke Miels said GSK was essentially angling to relaunch Shingrix in the aftermath of COVID-19 vaccine rollouts, which wreaked havoc on normal vaccination schedules. Amid coronavirus vaccine rollouts, Shingrix sales dipped nearly 50% in 2021's first quarter versus the same period in 2020.
The ongoing follow-up study Zoster-049 is tracking patients from two prior phase 3s—ZOE-50 and ZOE-70—for an additional six years. The original pair of pivotal trials found Shingrix was more than 90% effective in older adults over a follow-up period of roughly four years, GSK said in a release.
Outside the clinic, meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) lists the shot as providing a strong immune response in older adults “for at least the first seven years after vaccination.”
Older adults are at higher risk of developing shingles and “potentially severe complications” because the body’s immune system naturally weakens as it ages, GSK explained in a release. The disease arises from the reactivation of the varicella zoster virus (VZV). Unlike its milder sibling chicken pox, shingles can cause “unbearable pain” and, in some cases, that pain can persist for “months or even years” after a person’s shingles rash has faded, the company added.
GSK’s vaccine weds a non-live antigen with GSK’s adjuvant, which the company thinks could enable Shingrix to “help overcome the natural age-related decline in immunity” that makes it difficult to protect older adults from the disease.
Last year, ahead of GSK’s consumer health separation, the president of the company’s global vaccines business, Roger Connor, outlined bold ambitions to become the world’s “leading vaccines company.” GSK is banking on boosted sales from its meningitis franchise, plus a potential first-in-class respiratory syncytial virus (RSV) vaccine for older adults. But for the time being, Shingrix remains the British pharma’s “crown jewel,” Connor said during a call with investors last June.
GSK wasn’t too concerned about Shingrix competitors at the time, Connor noted, citing the shot’s 90% efficacy and more than four years of protection. That profile “sets the bar so high” that GSK feels “good about any potential attempts by competitors to enter this market in the coming years,” he said.
On the back of Wednesday’s interim trial readout, it appears Shingrix has raised the bar again.\
China's capital, Beijing, has dialled up measures to stop COVID, strengthening public checks and locking down some residential compounds after a quadrupling of its case load in recent weeks, just as a key Communist Party congress entered full swing.
The city of 21 million people on Thursday reported 18 new locally transmitted cases for the previous day, bringing the tally for the past 10 days to 197. That is four times more than the 49 infections detected in the previous 10-day period.
While the number of cases is very small compared with other countries, China's zero-COVID policy has compelled the capital to ratchet up preventive measures, particularly with the Communist Party holding its once-every-five-years congress this week, during which President Xi Jinping is expected to win a precedent-breaking third term as its leader.
Beijing's health authority called for stronger screening of risky individuals and meticulous checks on people entering crowded places including supermarkets and gyms.
Some residential compounds with suspected cases were put under three-day lockdowns that could be extended if new infections emerge.
"Ensure that no one is overlooked," Beijing's health authorities said.
In recent days, China has pledged to stick to its zero-COVID policy despite growing public frustration with it and its toll on the economy, quelling speculation that it would relax the hardline stance soon.
Shanghai, like many other Chinese cities battling sporadic COVID outbreaks, revealed this week that it was planning to build a 3,250-bed quarantine facility on a small island close to the city centre.
In April-May, the city of 25 million people endured a protracted lockdown after detecting hundreds of thousands of cases.
Other major cities including Beijing and Guangzhou have similar quarantine centres with thousands of beds. They also conduct regular public testing campaigns.China's capital, Beijing,
It was about eight to 10 years ago that the Left made a unilateral decision to shut down all opposition and any skepticism about climate change by pronouncing that the debate was over.
The “scientific consensus” had been reached, as if sent down on tablets from God, that mankind was causing the rapid warming of the planet. Period. End of argument. Doubters will be denounced as science deniers and stripped of their science credentials and muzzled by the speech police.
This idea of a scientific consensus is, of course, the diametric opposite of what scientific inquiry is all about. It is completely ahistorical. History’s greatest minds and inventors were people who challenged the conventional wisdom of the day. It’s an updated version of the Flat Earth Societies in the Middle Ages that would imprison those who dared question the scientific consensus of the time that the Earth was flat. The Spanish Inquisition tortured heretics who questioned papal orthodoxy.
The irony of the modern-day inquisitionists is that they are the very people who were the doomsayers of the 1970s who have been so consistently wrong about the future. These were the people who peddled the “population bomb,” which fizzled. They were the ones who said the Earth was cooling and that we were headed into another Ice Age. They were the ones who said we were running out of energy, food and farmland, and we were headed to a Malthusian nightmarish future. Wrong. Wrong. Wrong.
You’d think they would be humbled. But they are reiterating their certainty that they are the fountains of wisdom. And now they are getting dangerous with their heavy-handed tactics to squash dissent.
Consider what has happened in California—and soon coming to blue states near you. Democratic Gov. Gavin Newsom just signed a law that will revoke a physician’s medical license for conveying “misinformation” (defined as deviation from expert “consensus”) about COVID-19 and its treatments. Remember, by the way, this comes from the same people who said that the scientific consensus was to shut down schools and businesses to stop the spread of COVID-19 and that children as young as 5 had to be vaccinated—yet another set of the catastrophic and wrongheaded decision by “the experts.”
Since when does the government have the right to censor doctors? Whatever happened to doctor-patient confidentiality? Whatever happened to “my body, my choice”? Even Leana Wen, a former leader of Planned Parenthood and Baltimore’s health czar, warns this law “will have a chilling effect on medical practice.”
She worries that physicians could be suspended or have their licenses revoked “for offering nuanced guidance on a complex issue that is hardly settled by existing science.” Those accused of “misinformation” would be subject to discipline from the Medical Board of California, 13 of whose 15 members are appointed by none other than Newsom. We should call this the “inquisition panel.”
These are the political hacks who will decide what transgresses scientific consensus.
During COVID-19, both the Centers for Disease Control and Prevention and Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, resembled weather vanes as the “scientific consensus” seemed to shift on the pandemic from day to day. Newsom himself first insisted that travel restrictions were racist and unnecessary, that masks were superfluous and that California had the infection under control. If his censorship law had been around, would the doctors who disagreed with him have been punished for that?
We also now have major social media platforms censoring any skepticism about the effectiveness of the latest vaccines—even the opinions of major medical experts. Even when skeptics are wrong, they should be able to have their voices heard in a free society. Shouldn’t we all be able to agree on that basic truism?
If, God forbid, the COVID-19 speech restrictions are upheld by the courts, the next step will be to muzzle “climate misinformation.” Bans on free speech aren’t far behind in this new age of “scientific consensus,” which is apparently defined as whatever The New York Times and President Joe Biden’s administration decree the consensus to be. At that point, we can toss the First Amendment into the dustbin of history.
This is very scary and dangerous stuff the Left is imposing on us. Most alarming of all is that almost no commonsense liberals are speaking out against this madness. Have they been muzzled, too?
Following what's probably the single most horrifying and egregious example of a so-called "child friendly drag show" that we've ever seen, Texas Attorney General Ken Paxton has called for legal prosecution against those involved.
The event took place on Saturday in Plano, Texas - a large suburb of Dallas (of all places) - and involved a drag performer simulating a sex act in front of children at what the venue dubbed an "all ages" show.
"This is grotesque, disturbing behavior. Under Texas law, local district and county attorneys are charged with taking up the mantle to protect Texas kids by prosecuting these types of totally inappropriate acts," Paxton was quoted as saying after viewing disturbing footage of the event.
The performer can be seen going up to a small child, while adults in the background cheered the person on with dollar bills being waved, at which point the performer "flashed underwear in front of children" - as Daily Callerdescribed.
At least one young girl could be seen with a confused and disturbed look on her face. The dancer twerked to a song that had the lyrics, "My p*ssy good, p*ssy sweet. P*ssy good enough to eat" and "F*ck me all night"...
AG Paxton also urged greater legal protections for children in response: "What’s more, in 2023, the Texas Legislature should amend the Texas Penal Code to expressly prohibit this kind of grossly sexual conduct and empower my Office to prosecute when district and county attorneys refuse," he said.
Journalist Sara Gonzales of BlazeTV captured the video content, which has since gone viral and driven outrage:
"This is something that was overtly sexual," she said. "And now apparently the left is gaslighting me into thinking that I'm somehow the crazy one for having a problem with this."
An advertisement for an upcoming drag show said minors were allowed to attend with an accompanying parent or guardian, "Tucker Carlson Tonight" reported.
In further footage of the event, a little girl can be seen encouraged by the crowd to "tip" a drag dancer with dollar bills...
The restaurant and bar that hosted the event has boasted there will be more: "Following the October 15 event, Ebb & Flow’s Drag Brunch will take place on a monthly basis with dates to be announced soon," an event page cited by Fox News indicated.
Screenshot of the venue's public Facebook page and the prominent "Drag Brunch" advertisement:
It's as yet unclear whether the Plano Police or prosecutor will move forward with either an investigation or arrests; however, AG Paxton's statements are sure to draw increased scrutiny and pressure on the venue that hosted the drag event. Ebb & Flow in a statement given to the Dallas Morning News sought to defend what happened as "very tasteful".
Many observers have pointed out that typically bars offering sexually explicit shows maintain a strict 21 and over age policy, and yet examples abound lately of "LGBTQ-friendly" events actively targeting minors and young children.
